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Influence of manufacturing changes and formulation excipients on the
Influence of manufacturing changes and formulation excipients on the
AAPS 2004
direct determination of furosemide in solid oral dosage forms using
Poster T3053
direct determination of furosemide in solid oral dosage forms using
laser-induced breakdown spectroscopy (LIBS)
laser-induced breakdown spectroscopy (LIBS)
L. St-Onge1,*, P. Faustino2, M. Tourigny3, M. Sabsabi1
L. St-Onge1,*, P. Faustino2, M. Tourigny3, M. Sabsabi1
1National Research Council of Canada (IMI), Boucherville (QC), Canada; 2Food & Drug Administration (CDER), Silver Spring (MD), U.S.A.; 3Pharma Laser, Boucherville (QC), Canada 1National Research Council of Canada (IMI), Boucherville (QC), Spring (MD), U.S.A.; 3Pharma Laser, Boucherville (QC), Canada * Corresponding author: louis.st-onge@cnrc-nrc.gc.ca LIBS spectra
Internal standardization
To investigate the influence of
Influence of magnesium stearate content and
z This study was carried out using a PharmaLIBS™ Model 200 manufacturing changes and formulation
instrument (Pharma Laser, Boucherville, Canada) compression strength (in direct compression tablets)
excipients on the direct determination of
furosemide by LIBS in solid dosage forms.
z A pulsed Nd:YAG laser (λ=1064 nm, 7 ns, 200 mJ/pulse) produced a gaseous plasma directly at the surface of the Approach: Various furosemide formulations with the same drug concentration were analyzed to identify possible matrix effects z The optical emission spectrum was resolved, and furosemide was identified unambiguously through emission of atomic z Each tablet analysis was based on a total of 60 laser pulses (6 sites, 10 pulses/site), with a one minute duration Background
In LIBS, a laser pulse is focused directly on the sample, in ambient air, leading to the vaporization of Joulemeter
some material and the formation of a transient Steering
Nd:YAG Laser
luminous plasma. Elemental components of the sample are detected from the plasma emission, F ib e r O p tic
through optical emission spectroscopy.
LIBS has been used in a variety of applications Influence of manufacturing changes
Detector
involving solid, liquid or gas analysis.1 (for lactose-matrix tablets)
Spectrograph
Sample Tray
Influence of lactose/Avicel ratio (in direct compression tablets)
Pharmaceutical applications of LIBS include the For similar formulations, the LIBS signal analysis of active pharmaceutical ingredients (API) XY-Rot Stage
1 DA Rusak et al., Crit Rev Anal Chem 27 (1997) 257-90.
S Béchard, Pharm Formul Qual 3 (2001) 37-40.
MD Mowery et al., J Pharm Biomed Anal 28 (2002) 935-43.
L St-Onge et al., Spectrochim Acta B 57 (2002) 1131-40.
5 Other publications available at http://www.pharmalaser.com Working principle of the PharmaLIBS™ 200 instrument
Using the Cl or S emission provides similar intensities, and therefore sensitivity, for 80-mg furosemide tablets (320-mg total weight) were manufactured by direct compression or wet granulation. Ten quantitation of furosemide. The intensities are experimental furosemide formulations were investigated, with the same furosemide content, but differing mainly in systematically lower in a lactose matrix.
their relative excipient content of Avicel, lactose and magnesium stearate.
Conclusions
Conclusions
Direct Compression formulations
Wet Granulation formulations
• Either of chlorine or sulfur signals could be used for quantitating Formulation
Furosemide
MgStearate
Formulation
Furosemide
MgStearate
Povidone
ependence on the formulation and manufacturing than the o. ctose/Avicel ratio was the parameter of the formulation that The Mg signal is more affected than the C signal by the matrix, which explains why the Mg/C ratio S and Cl are specific to
still depends on the matrix (as with Cl/C and S/C). furosemide (in this
In the present case, using internal standardization The Mg/C ratio is seen to decrease gradually up to does not compensate for the change in matrix. On formulation) and can be used
60% lactose in the mixture, and is approximately average, the Cl/C ratio in lactose is 74% that in constant thereafter. The overall decrease in signal for quantitation.
Avicel. For S/C, the decrease is somewhat greater, going from Avicel to lactose is the same as monitoring of pharmaceuticals during manufacturing changes.
We acknowledge the involvement of Yves Mouget, Ph.D., in early phases of this work.

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